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Analysis of the Prevalence of Sensitization to Plants Containing Gibberellins Using Realistic Skin Prick Tests

Study Purpose

Gibberellin-related proteins (GRPs) are proteins contained in both pollens and vegetables and are associated with an increased risk of severe food allergy reactions. The best characterized one the only one for which a specific IgE (Immunoglobulin E) may be dosed in current clinical practice is Pru p 7, an allergen contained in peaches (Prunus persica). Sensitization to GRPs seems to be greater in areas with high exposure to pollens of the Cupressaceae family (as in the Montpellier region in Southern France); a subtype of Cupressaceae pollinosis, characterized by sensitization to Pru p 7 has been shown to be responsible for severe peach allergies. To date, there has been no real analysis of the prevalence of sensitization to GRPs, or of possible cross-sensitization between plants and foods containing GRPs. Main food containing GRPs with a high level of homology with Pru p 7 include apples (Malus domestica, 97.3%), sesame (Sesamum indicum, 91.9%), carrots (Daucus carota subsp. Sativus, 88.9%), lemons and oranges (different species, with a homology of 87.3%). If investigators consider that sensitization to GRPs could be associated with severe allergic hypersensitivity reactions, it is important to detect the prevalence of sensitization to these allergens and to find sensitization profiles for these patients in order to gain a better understanding of this type of allergy and offer a more appropriate and preventive management to allergic patients. This remains today a major challenge for the allergy community in the Mediterranean region. This study aims to investigate the rate of sensitization to peach and 5 other allergens containing gibberellins, chosen on the basis of their homology with Pru p 7 (the gibberellin from Prunus persica): carrot, lemon, orange, apple and sesame.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 5 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients aged at least 5 years.
  • - Patients consulting at the Allergy Unit of the University Hospital of Montpellier for any type of allergy work-up/evaluation.
  • - Oral consent from the patient and, where applicable, from at least one of the patient's legal representatives in the case of minors.

Exclusion Criteria:

  • - Patients treated with antihistamines or psychotropic drugs with antihistaminic action during the 7 days prior to inclusion.
  • - Patients with pathologies that prevent the performance of prick tests (e.g. severe peripheral neuropathy, cutaneous anergy).
  • - Patients with dermographism.
  • - Patient taking part in another study which may influence the results of the prick tests.
  • - Patients in an exclusion period determined by a previous study.
  • - Pregnant, parturient or breast-feeding women.
  • - Patients or their legal representatives under court protection, guardianship or trusteeship.
  • - Patients or their legal representatives who are not members or beneficiaries of a health insurance scheme.
  • - Patient or his/her legal representative unable to read and understand French fluently.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06183398
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Montpellier
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Davide CAIMMI, MD
Principal Investigator Affiliation University Hospital, Montpellier
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy
Arms & Interventions

Arms

Experimental: Eligible patients

Interventions

Other: - Skin prick test

Specific skin prick tests for 6 raw food: peach, apple, sesame, carrot, lemon and orange

Contact a Trial Team

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International Sites

University Hospital of Montpellier, Montpellier, France

Status

Recruiting

Address

University Hospital of Montpellier

Montpellier, , 34295

Site Contact

Davide CAIMMI, MD

[email protected]

+33467336112

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